MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ENDORETURN ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number ER23B

Device Problem Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 08/11/2022

Event Type  Injury  

Event Description

It was reported that after cannulating the femoral artery with the er23b a test dose was performed.High line pressures of the arterial cannula was observed.An echo exam was performed showing a dissection of the artery.The cannulation process was stopped and decannulated once it was determined it was safe to do so.While surgeon does not believe the er23 cannula was defective causing the dissection they do believe the design of the cannula makes it difficult to safely cannulate the groin.Additionally he stated the transition from the obturator to cannula is not smooth causing a concern for dissection and mentioned the bluntness of the obturator.The patient did not have any further complication related to the arterial dissection and the case was aborted and schedule for another date.

Manufacturer Narrative

The subject device is not available for evaluation, device not returned.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Updated sections: h6 health effect - impact code, type of investigation, investigation findings, and investigation conclusions.A dissection is a tear in the inner lining of the vasculature.As a result, blood flows through this newly created false channel, which raises a flap that can occlude blood flow in the true lumen.This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention.There are small tears that can occur that do not result in significant disturbances to blood flow and do not require intervention.Dissections typically occur as a result of the patient's diseased vasculature and technical errors resulting during the cannulation process.The device history record (dhr) could not be reviewed, as the device serial number was not provided.Based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined; however, patient and/or procedural factors may have contributed.

• Brand Name: EDWARDS ENDORETURN ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15366778
• MDR Text Key: 299355812
• Report Number: 2015691-2022-07731
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER23B
• Device Catalogue Number: ER23B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male